MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH IH-COM V5.0

Catalog Number	009101
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our combined initial and final report on this incident.
Event or Problem Description
The customer reported that a wrong result was linked to the wrong patient demographics on ih-com on the ih-1000 instrument.Datafiles of the affected ih-1000 were retrieved by one of our field service engineers and investigated.The preliminary investigation shows the mismatch is linked to a user action, where user patient cxxxxxx, mxxxxxx mrn (b)(6) was merged with gxxxxx, mxxx mrn (b)(6).This was done on january 9th at 03:09.After the first change of patient demographics was done, the same user performed several changes on this sample id.Evidence was found in the ih-com system log.Once the patient files were merged, the following samples were linked to the demographics of patient cxxxxxx, mxxxxxx (mrn (b)(6)), samples were manually confirmed by the customer as correct for this patient.For patient gxxxxx, mxxx mrn (b)(6), the patient history only includes 1 sample, that was processed after the merging event.The results prior to this event are now included in patients' cxxxxxx, mxxxxxx file.In investigating the incident involving ih-com sending the wrong result to the wrong patient, a detailed analysis of the database provided during the case escalation was conducted, specifically focusing on ih-com version 5.0.9.The examination revealed that the issue stemmed from a manual data merging action by the lab user "jzl" on january 9th at 03:09.During this operation, patient cxxxxxx (mrn (b)(6)) wascombined with patient gxxxxx (mrn (b)(6)).Despite the software's standard protocol of issuing a warning message before merging data, "jzl" acknowledged the warning and proceeded with the operation, resulting in the integration of gxxxxx's data into cxxxxxx's file.Importantly, there is no evidence of a software malfunction.We pointed out to the user the importance of attentiveness and adherence to systemwarnings during manualdata manipulations.The software continues to operate as designed, and we recommended reinforcing to the user awareness to minimize the likelihood of similar incidents in the future.

• Brand Name: IH-COM V5.0
• Common Device Name: IH-COM V5.0
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• Manufacturer Contact: martina benkert ; industriestrasse 1; dreieich, 63303 ; GM 63303
• MDR Report Key: 18648106
• Report Number: 9610824-2024-00001
• Device Sequence Number: 7111360
• Product Code: KSZ
• UDI-Device Identifier: 07611969234417
• UDI-Public: (01)07611969234417
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: BK180275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 009101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: IH-1000, SN (B)(6).
• Patient Sex: Unknown